1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Macco Organiques Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
6Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
7Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Other quality system
The recorded information or details were inadequate.
10Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
11Other quality system
The assessment to release finished products was inadequate.
12Equipment and facility
The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
13Laboratory and QC controls
The validation of test methods was inadequate.
14Equipment and facility
The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-20. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
